Is Alvotech Hf FDA approved?

Alvotech Hf holds 1 FDA-registered establishment in Iceland. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Alvotech Hf's drugs manufactured?

The FDA register lists Reykjavik. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Alvotech Hf

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: Iceland

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Alvotech Hf	Saemundargotu 15-19, Reykjavik, 102, Iceland (ISL)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3013702557500791692

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Common questions

Is Alvotech Hf FDA approved?: Alvotech Hf holds 1 FDA-registered establishment in Iceland. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Alvotech Hf's drugs manufactured?: The FDA register lists Reykjavik. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.